BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 3122172 · Received May 21, 2013

    Report

    Report Number
    1823260-2013-03070
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 21, 2013
    Report Date
    June 5, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT KNOWN IF THE INITIAL REPORTER HAS OR INTENDS TO REPORT THE EVENT TO FDA.

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH HYPOTENSION (83/44 MM/HG), ATRIAL FIBRILLATION, ABDOMINAL AORTIC ANEURYSM, CHRONIC RENAL FAILURE, AND RESPIRATORY DISTRESS. AT AN UNSPECIFIED TIME PATIENT WAS REPORTEDLY SEDATED, INTUBATED, AND PLACED ON A MECHANICAL VENTILATOR. PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013, WITH AN INITIAL DIAGNOSIS OF SEPTIC SHOCK. REPORTER STATED THAT ON (B)(6) 2013 PATIENT WAS TREATED WITH 100 G, 50 G, AND 50 G, RESPECTIVELY, OF AN INTRAVENOUS IMMUNE GLOBULIN, OCTAGAM, WHICH CONTAINS MALTOSE, A LABELED INTERFERENT FOR COMFORT CURVE TEST STRIPS. REPORTER PROVIDED THE FOLLOWING PATIENT BLOOD GLUCOSE RESULTS, FROM (B)(6) 2013, OBTAINED FROM THE INFORM SYSTEM AND AN UNSPECIFIED LABORATORY INSTRUMENT: (B)(6) 2013: 350 MG/DL, INFORM SYSTEM, 06:12 AM, 298 MG/DL, INFORM SYSTEM, 08:32 AM 245 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 09:32 AM, (PATIENT WAS STARTED ON AN INSULIN DRIP) 281 MG/DL, INFORM SYSTEM, 10:04 AM 277 MG/DL, INFORM SYSTEM, 11:57 AM, 237 MG/DL, INFORM SYSTEM, 02:07 PM, 234 MG/DL, INFORM SYSTEM, 04:13 PM, 241 MG/DL, INFORM SYSTEM, 06:13 PM, 232 MG/DL, INFORM SYSTEM, 08:08 PM, 219 MG/DL, INFORM SYSTEM, 10:05 PM, (B)(6) 2013: 173 MG/DL, INFORM SYSTEM, 12:28 AM 179 MG/DL, INFORM SYSTEM, 02:00 AM, 17 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 06:18 AM 159 MG/DL, INFORM SYSTEM, 06:20 AM, 172 MG/DL, INFORM SYSTEM, 07:17 AM, 12 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 08:00 AM - AT 09:10 AM, PATIENT WAS TREATED WITH 1 AMP OF D50 146 MG/DL, INFORM SYSTEM, 08:22 AM, 9 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 08:50 AM, 567 MG/DL, INFORM SYSTEM, 09:35 AM, 581 MG/DL, INFORM SYSTEM, 09:38 AM, 515 MG/DL, INFORM SYSTEM, 09:42 AM, 134 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 09:50 AM, 92 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 11:50 AM, 149 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 12:54 PM, 308 MG/DL, INFORM SYSTEM, 03:25 PM, 335 MG/DL, INFORM SYSTEM, 03:26 PM, 327 MG/DL, INFORM SYSTEM, 05:55 PM, 176 MG/DL, LABORATORY TEST, SAMPLE OBTAINED AT 06:00 PM, ALTHOUGH REPORTER NOTED THAT, PRIOR TO THE LABORATORY TEST AT 06:18 AM ON (B)(6) 2013, PATIENT'S INSULIN DOSAGE WAS INCREASED BASED ON VALUES OBTAINED ON THE INFORM SYSTEM, NO SPECIFIC INFORMATION REGARDING THE AMOUNT, TIMING, OR RATE OF INSULIN ADMINISTRATION WAS REPORTED. AT AN UNSPECIFIED TIME, ON (B)(6) 2013, INSULIN THERAPY WAS DISCONTINUED AND GLUCOSE MONITORING, VIA THE INFORM SYSTEM, CEASED AT 5:55 PM. REPORTER NOTED THAT PATIENT HAD NO HISTORY OF DIABETES MELLITUS. ALSO, REPORTER STATED THAT THE PATIENT HAD BEEN SEDATED THROUGHOUT THE EVENT, AND, AT THE TIME OF THE INITIAL REPORT, REMAINED SO. ON (B)(6) 2013, THE MANUFACTURER RECEIVED ADDITIONAL INFORMATION FROM THE USER FACILITY REGARDING THIS EVENT. THE INITIAL REPORTER STATED THAT THE PATIENT SUBSEQUENTLY PASSED AWAY (DATE OF DEATH NOT PROVIDED) WITH CAUSE OF DEATH LISTED AS TOXIC SHOCK AND MULTIPLE ORGAN FAILURE. REPORTER NOTED THAT PATIENT'S DEATH WAS NOT RELATED TO ANY ACTION OR INACTION BASED ON THE OUTPUT OF THE INFORM SYSTEM. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223682 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551766

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR Required Intervention NOREPINEPHRINE| CLINDAMYCIN| CEFTRIAXONE SODIUM| CHLORHEXIDINA GLUCONATE| REGULAR INSULIN| HYDROCORTISONE| PROPOFOL| PANTOPRAZOLE SODIUM| COUMADIN| OCTAGAM| DEXTROSE 5%| GENTAMICIN SULFATGE